| Methods |
Study design: Randomised controlled trial
Randomisation procedure: Randomised and paired into two groups by age and sex. Allocation concealment: Not stated.
Blinding of outcome assessors: Unclear
Length of intervention: 12 weeks
Intention‐to‐treat analysis: Not done |
| Participants |
Diagnosis: Non‐insulin dependent diabetes mellitus Setting: Out‐patients of Diabetic Clinic
n=40 Intervention, 19; control, 19
Mean age: 56.6+‐ 6.6 yr
Male/female: 26 female, 14 male. Inclusion criteria: persistent hyperglycaemia, despite repeated diet conselling and oral treatment with glibenclamide and metformin. Exclusion criteria: Evidence of ischemic heart disease, elevated systolic blood pressure (>240 mm Hg), could not use bicycle ergometer, wanting to be part of the exercise group only
Geographical location: Israel |
| Interventions |
Intervention: Exercise
Times per week: 3 group sessions (2 under direct supervision of trainer, 1 unsupervised)
Duration of each session: about 50 minutes.
Intensity: moderate aerobic exercise. Compliance assessed by a diary. Control: Same lifestyle as before. Diet and lifestyle questionnaire once monthly. Running, rowing and cycling. Swimming or cycling were the unsupervised sessions. |
| Outcomes |
Glycated haemoglobin, triglycerides, VO2 maximum, Body Mass Index, total cholesterol, HDL‐C, fasting glucose, fructosamine, resting heart rate |
| Notes |
1 in control group had a stroke, 1 in intervention group did not attend many meetings and missed blood tests.
There was a post‐intervention follow‐up one year after the study ended |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
